Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

Обзор

Post-operative management of shoulder surgery patients, particularly in terms of pain management and follow-up, can vary from one center to another, influencing clinical outcomes and patient satisfaction. The aim of this study is to compare two approaches to post-operative follow-up in two distinct centers: structured follow-up using the Vivalto-Dom protocol in Paris, and autonomous follow-up through contact with a nurse in Saint-Grégoire. The hypothesis is that these differences in the care pathway will affect pain management, comfort and patient satisfaction. By controlling for operative variability (a single surgeon operating in both centers), the study will identify the most effective follow-up practices for improving post-operative management, with the ultimate aim of optimizing quality of care and reducing post-operative complications.

Вмешательства

• Процедура Vivalto Dom follow-up
  During the pre-operative consultation, the patient receives a prescription for medication (analgesics and anti-inflammatories) for immediate post-operative pain relief. They also receive a "patient information booklet" (see appendix 6). On discharge from surgery, the patient returns home with Vivalto Dom in charge of nursing care and follow-up medication. Vivalto Dom is a homecare structure whose mission is to coordinate the discharge of patients back home, and to ensure continuity of overall c
• Процедура Liberal follow-up
  The pre-operative and operative course (fasting rules, skin preparation, hospitalization, surgery) is the same as for all routine care patients. The patient is informed before surgery that he or she must make an appointment with a nurse for post-operative care at home; a prescription for medication (analgesics and anti-inflammatories) has been given by the anaesthetist for immediate analgesic treatment, and on discharge from hospital he or she receives another prescription from the surgeon for o

Первичные конечные точки

• Pain intensity (VAS) [Срок оценки: 3 days, 6 weeks, 3 months and 6 months after surgery]

Вторичные конечные точки (2)

• Patient comfort (Likert scale) [Срок оценки: 3 days, 6 weeks, 3 months and 6 months after surgery]
• Postoperative complications [Срок оценки: 3 days, 6 weeks, 3 months and 6 months after surgery]

Критерии участия

Критерии включения

• Patient eligible for one of the following 4 types of surgery: Simple non-repair arthroscopic surgery (acromion, calcification), arthroscopic repair surgery (cuff, DAS, bankart), open surgery without prosthesis (ligamentoplasty, bone block), open surgery with prosthesis (inverted prosthesis, anatomic prosthesis, etc.).

Критерии исключения

• Patients with one or more communication disorders.
• Pregnant or breast-feeding patients
• Patients not covered by a social security scheme
• Refusal to participate in research
• Patients unable to understand or give informed consent
• Patients under guardianship, deprived of liberty or under court protection
• Patients with past or present drug addiction
• Patients with neuropathy
• Patients with cognitive disorders
• Patients with chronic illnesses or inflammatory pathologies leading to chronic pain.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• Clinique Victor Hugo — Paris
• Centre hospitalier privé Saint-Grégoire — Saint-Grégoire

Идентификаторы

NCT: NCT06808269 · 2024-28-CVH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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